Trials Methodology Research at
University of Birmingham
Professor Lucinda (Cindy) Billingham
Professor of Biostatistics
Di...
The Need for Trials
Methodology Research
Users

Change
Clinical
Practice

Evidence
Synthesis

Pre-trial
Development

Add-o...
MRC Network of Hubs for Trials
Methodology Research (HTMR)
All-Ireland Hub
led by Professor Mike Clarke

Dr Adrian Mander
...
Structure of the Midland Hub
University of Birmingham
College of Medical and Dental Sciences
School of Cancer Sciences
Can...
Midland Hub Resources (2009-2014)
Director (60%)

Day-to-day management; support and mentorship
to RFs and PhD students; e...
Mission Statement of the Midland Hub
‘The mission of the MRC Midland Hub for
Trials Methodology Research is to be a
centre...
Qualitative research methods

Decision modelling

Economic evaluation

Evaluations of Service Delivery and
Policy Interven...
Some Highlights
• Patient-reported outcomes (PRO): international collaboration to develop
the CONSORT PRO and improve stan...
Some Highlights (cont)
• Implementing novel designs to enable practice-changing trials in rare
cancers
– Funding for trial...
Looking to the Future

• Funding for the Midland Hub will cease on May 31st 2014
• The development of the Midland Hub esta...
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BCCT Showcase - Trials Methodology Research

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BCCT Showcase - Trials Methodology Research

  1. 1. Trials Methodology Research at University of Birmingham Professor Lucinda (Cindy) Billingham Professor of Biostatistics Director, MRC Midland Hub for Trials Methodology Research Director of Statistics, Cancer Research UK Clinical Trials Unit University of Birmingham BCCT Showcase, University of Birmingham November 27th 2013
  2. 2. The Need for Trials Methodology Research Users Change Clinical Practice Evidence Synthesis Pre-trial Development Add-on translational studies Established expertise New areas Trial Analysis Change Clinical Practice Trial Conduct Phase I, II, III Trial Set-Up and Design
  3. 3. MRC Network of Hubs for Trials Methodology Research (HTMR) All-Ireland Hub led by Professor Mike Clarke Dr Adrian Mander www.methodologyhubs.mrc.ac.uk
  4. 4. Structure of the Midland Hub University of Birmingham College of Medical and Dental Sciences School of Cancer Sciences Cancer Research UK Clinical Trials Unit (CRCTU) Birmingham Clinical Trials Unit (BCTU) School of Health and Population Sciences Primary Care Clinical Sciences Unit Public Health, Epidemiology & Biostatistics Unit Health Economics Unit Birmingham Centre for Clinical Trials (BCCT) Billingham Wheatley Johnson [Stocken] Gray [Ives] Calvert Delaney Freemantle Hobbs Wilson (Draper) Deeks Lilford Zeegers [Girling] [Riley] [Hemming] Bryan [Barton] [Coast] (Al-Janabi) Billingham Wheatley Deeks [Ives] Calvert Draper Lilford Deeks Girling Hemming Lilford Riley Coast [Barton] Director: Professor Lucinda Billingham Deputy Director: Dr Richard Riley [Key collaborators who are active MHTMR researchers & MHTMR Management Group members] (Key collaborators who are supervisors for MHTMR PhD projects)
  5. 5. Midland Hub Resources (2009-2014) Director (60%) Day-to-day management; support and mentorship to RFs and PhD students; ensure successful delivery Hub programme; networking 12 Hub Investigators Supervision and development of research projects and contributions to training and advisory service 3 Research Fellows Methodological research projects Project grant applications Provision and coordination of advice facility Training and support to PhD students 1 Senior Administrator Support Director, Investigators, Research Fellows Support training programme and PhD students Organise Hub meetings and events 5 PhD Students Methodological development Plus other affiliated RFs and PhD students
  6. 6. Mission Statement of the Midland Hub ‘The mission of the MRC Midland Hub for Trials Methodology Research is to be a centre of excellence for trials methodology research, providing researchers undertaking trials with appropriate and innovative methodology for design, conduct, analysis and reporting, thereby improving the quality of trials and ultimately patient care.’ Research Programme Training Programme Advice, Support and Dissemination Function
  7. 7. Qualitative research methods Decision modelling Economic evaluation Evaluations of Service Delivery and Policy Interventions (Lilford, Girling, Hemming) Cluster trials and stepped-wedge designs Improving the Quality of Consent to Trials (Draper) Joint modelling of longitudinal and event data Trials in Rare Diseases (Wheatley, Billingham) Statistical modelling of time-to-event data Early Phase Clinical Trials (Billingham in collaboration with O’Quigley) Systematic reviews and meta-analysis methods Stratified Medicine and Test Evaluation (Riley, Deeks) Bayesian methods Outcome Measures for Trials (Calvert, Coast, Billingham) General clinical trial design, conduct and analysis Key Research Themes in Midland Hub
  8. 8. Some Highlights • Patient-reported outcomes (PRO): international collaboration to develop the CONSORT PRO and improve standards of reporting – Calvert M, Blazeby J, Altman D et al; Reporting of patient-reported outcomes in randomised trials: the CONSORT PRO extension; JAMA 2013 • Stratified medicine: review to establish methodological standards for evaluating predictive biomarkers – Malottki K, Biswas M, Deeks J, Riley R, Craddock C, Johnson P, Billingham L; Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers; on review with BMJ Open – Billingham L, Deeks J, Riley R, Malottki K, Middleton G, Morton D, Craddock C; Stratified medicine: methods for evaluating predictive biomarkers for treatment of cancer; Grant submission to Cancer Research UK Population Research Committee Nov 2013 • Implementing improved methodology for early phase trials in cancer in CRCTU – Craddock C, Yap C et al; A phase I/II trial of combined 5-azacitidine and lenalidomide salvage therapy in patients with acute myeloid leukaemia who relapse after allogenic stem cell transplantation; funded by Leukaemia and Lymphoma Research
  9. 9. Some Highlights (cont) • Implementing novel designs to enable practice-changing trials in rare cancers – Funding for trials with novel designs in paediatric oncology run by Childrens Cancer Trials Team in CRCTU (led by Wheatley) – Funding from CRUK for phase III trial in penile cancer (Billingham in collaboration with International Rare Cancers Initiative and ICR Trials Unit) • Enhancing results of an NIHR funded trial run at BCTU that failed to recruit using Bayesian methods – Morris RK, Malin GL, Quinlan-Jones E, Middleton LJ, Hemming K, Burke D, Daniels JP, Khan K, Deeks J, Kilby MD; Percutaneous vesicoamniotic shunting versus conservative management for fetal lower urinary tract obstruction (PLUTO): a randomised trial; Lancet 2013 • Influencing decisions of the National Research Ethics Service regarding patient information for trials – Kirkby HM, Calvert M, McManus RJ, Draper H; Informing potential participants about research; observational study with an embedded randomised controlled trial; PloS one 2013
  10. 10. Looking to the Future • Funding for the Midland Hub will cease on May 31st 2014 • The development of the Midland Hub established a team of researchers involved in trials methodology and – facilitated some important research projects that should benefit trials practitioners in the future – established an infrastructure from which to continue as a centre of excellence for trials methodology research into the future within BCCT
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